A method and device for introducing a powdered or particulare substance into a person""s nostril
The present invention relates to a method for introducing a powdered or particulate substance into a persons nostril or nostrils. It is known to disperse the powdered or particulate substance in an air flow which is created by compressing a rubber bulb arranged at one end of a tube or hose having an opposite free end, which may be inserted into the nostril.
The present invention provides such method for introducing a powdered or particulate substance into a persons nostril or nostrils, said method comprising arranging a dose of the substance within an inner cavity of a tubular body, inserting a first open end of the tubular body communicating with the inner cavity between the persons lips, inserting a second open end of the tubular body communicating with the inner cavity into said nostril, and blowing into the first open end of the tubular body so as to create a flow of air through the inner cavity of the tubular body for transferring the substance to the nostril.
In the method according to the invention the person or patient being treated is creating the necessary air flow through the inner cavity of the tubular member by means of her/his expiratory blow. It has been found that the user will automatically close the connection between the nostrils and the throat by the uvula when blowing. Therefore, the powdered or particulate substance is substantially prevented from penetrating into the users trachea and gullet. Therefore, by using the method according to the invention almost the total amount of the substance blown into the nostril is applied to the mucous membrane within the nostril.
The method according to the invention may be carried out by means of a tubular body which has or may be given such a shape that one open end thereof may be inserted between the users lips while the opposite open end is inserted into the users nostril. The said second or opposite end of the tubular body may be bifurcated so as to form a pair of adjacent open ends which may be inserted into the users nostrils.
Prior to inserting the opposite ends of the tubular body into the mouth and the nostril, respectively, a suitable dose of any kind of a suitable type of an active substance is inserted into the inner cavity of the tubular body. This substance may for example be a substance or vaccine active against allergic reactions, such as allergy against pollen, animal hair, etc. Such substance or vaccine may be composed to the individual user. The substance may, alternatively, be any pharmaceutical or other product which is to be applied to the mucous membrane within a nostril, such as an antihistamine.
When a user or patient is about to insert the first open end of the tubular body into his or her mouth the patient""s respiration may cause that the first open end of the tubular body is unintentionally exposed to a light suction or over pressure. This may cause unintentional movement of the powdered or particulate substance within or out from the tubular body. The risk of such unintentional movement of the powdered substance may be diminished when at least one venting opening is defined in the tubular body wall at or adjacent to said first open end. However, when the user or patient has inserted the first open end between the lips and is ready to blow through the tubular body the venting opening will be covered by the lips or be located within the oral cavity of the user.
At least one cross-sectional restriction may be formed in the inner cavity of the tubular body such that the dose of powdered or particulate substance is arranged downstream of the restriction in relation to the direction of the air flow transferring the powdered or particulate substance to the nostril. Such cross-sectional restriction will encourage the patient or user to blow more forcefully into the tubular body. Furthermore, the velocity of the air flow in the gorge or throat defined by the restriction will be relatively high which may assist in obtaining a good dispersion of the powdered or particulate substance in the air flow. When a venting opening as well as a restriction are formed at or adjacent to the open first end of the tubular body the restriction is preferably arranged downstream of the venting opening.
When used in a method according to the invention the efficiency of the tubular body may be further increased by defining the restriction by yieldable restriction means which are moveable between a first restricting position and a second position in which the restriction defined by the restriction means is substantially less. Such yieldable restriction means may yield and move from the first restricting position to the second non-restricting or less restricting position when the pressure difference between the inner cavity upstream of the restriction means and downstream of the restriction means or outside the tubular body has obtained a predetermined value. This means that a sudden forceful airflow may be created within the inner cavity of the tubular body when the restriction means are moving from their first to their second position.
The present invention also relates to a device for applying a powdered or particulate substance to a mucous membrane within a nostril of a user of the device, said device comprising a tubular body defining an inner flow passage extending longitudinally between a nasal piece ((12) at a first end of the tubular body to be inserted into the nostril of the user and an opposite second end of said body, and the device according to the invention is characterised in that the second end of the tubular body defines a mouthpiece to be inserted between the lips of the user, the length and the shape of the tubular body being such that the nasal piece and the mouthpiece may at the same time be positioned in the nostril and between the lips, respectively, of the user, whereby the user may blow into the mouthpiece end of the flow passage and transfer powdered or particulate substance arranged within the flow passage of the tubular body to the nostril in a dispensed condition.
The tubular body may have any suitable shape allowing the mouthpiece and the nasal piece to be correctly inserted into the mouth and nostril, respectively, of the user.
This may, for example, be obtained when the tubular body comprises an intermediate bent or bendable section. This means that the tubular body may have or may be given an angular shape. As an example, the tubular body or at least an intermediate part thereof may be made from a deformable or flexible material. Alternatively, the bent and/or bendable section may comprise adjacent, peripherally extending corrugations allowing the tubular body to be bent even when it is made from a relatively stiff material. It has been found that the inner troughs and ridges of the corrugations extending transversely to the air flow promote atomization of the particulate substance and the dispersion of the substance in the air flowing through the air flow passage. This effect is improved when the corrugations have a substantially serrated outline when viewed in a longitudinal, axial section. This means that the bottoms of the corrugation troughs and the peaks of the corrugation ridges are relatively sharp.
The device according to the invention is preferably of the disposable type. Therefore, the device may comprise a dose of a powdered or particulate substance arranged within the flow passage. When the device has been used once and the substance has been transferred to the mucous membrane of a nostril or the nostrils of a person, the device may be discarded. The said substance may be of any type which could advantageously be introduced into a nostril dispersed in an air flow, such as a substance or vaccine active against allergy, a pharmaceutical or a medicament.
When the tubular body contains a dose of the powdered or particulate substance, the opposite free ends of the mouthpiece and the nasal piece, respectively, are preferably sealed or closed by closure means, which are to be removed or opened prior to use of the device. Such closure means may be a membrane which could be removed or ruptured. In the preferred embodiment, however, the closure means comprise at least one cap member removably arranged on the free ends of the mouth piece and the nasal piece, respectively. Thus, the tubular body may be closed by means of a closure cap arranged at each of its opposite ends. However, when the tubular body has an intermediate bendable section, the mouthpiece and the nasal piece may coextend and have their free ends positioned closely adjacent prior to use of the device. This means that the tubular body may be substantially U-shaped, and the closely adjacent free ends may then be closed by a common interval cap member.
The inner and outer cross-sections of the tubular body may vary along the length of the tubular body. In the preferred embodiment, however, the tubular body has a substantially uniform inner and outer cross-sectional shape along its length. Thus, the device according to the invention may be made very simple and may be formed similar to a drinking straw.
In order to obtain a good dispersion of a particulate or powdered substance in the air flowing through the air flow passage the velocity of the air must be relatively high. Therefore, the flow passage of the tubular body preferably has a cross-sectional area not exceeding 75 mm2 and preferably not more than 70 mm2. In a preferred embodiment the cross-sectional areas of the flow passage do not exceed 50 mm2 and are preferably 7-35 mm2 or about 20 mm2.
The device according to the invention may further comprise at least one venting opening defined in the tubular body at or adjacent to said first end. The device according to the invention may further comprise restriction means forming at least one cross-sectional restriction within the inner cavity of the tubular body, and a dose of powdered or particulate substance may then be arranged downstream of said restriction means before the device is used. This means that air flowing through the tubular body when a user is blowing through the mouthpiece thereof will pass the restriction means before passing the dose of powdered or particulate substance.
As explained above the restriction means are preferably yieldable so as to moveable between a first restriction position and a second non-restricting or less restricting position. Such yielding restriction means may comprise a flap which in said first position covers at least part of the cross-section of the inner cavity of the tubular body and which may be deflected and moved to a less restricting position. Alternatively, the yielding restriction means may comprise a one-way valve of any kind having a valve body which is biassed towards a closed or restricting position and which may be moved to an open or less restricting position when the biassing force is overcome by a pressure generated at the open first end or mouthpiece of the tubular body when a user or patient is blowing therein. The valve body of the one-way valve may be in the form of a flap or the like.
Preferably, the device according to the invention does not comprise parts which are separate from the tubular body because such separate parts would not only increase the manufacturing costs of the device according to the invention, but would also involve a risk to the user. Therefore, the flap, whether forming part of a one-way valve or not, is preferably an integral part of the tubular body wall. This may, for example, be obtained when the flap is cut from the tubular body wall and bent inwardly into the inner cavity of the tubular body so as to define a venting opening immediately upstream of the flap. The opening is preferably formed at or immediately adjacent to the mouthpiece so that the opening may be covered by the lips of the user or be located within the oral cavity of a user blowing through the tubular body.
Alternatively, the flap may extend into the inner cavity or into the open end of the tubular body from the free edge of the mouthpiece.
In the preferred embodiment, however, the restriction means comprise inwardly compressible or pinchable parts of the tubular body wall. Such compressible wall parts may be longitudinal sections of the tubular body having a smaller wall thickness and/or are made from a softer or more elastic material than the remaining part of the tubular body. In the preferred embodiment, however, the wall of the tubular body has substantially the same characteristics along the total length of the tubular body. In such case the tubular body may be compressible along its total length and the xe2x80x9ccompressible partsxe2x80x9d or xe2x80x9cpinchable partsxe2x80x9d may be marked, for example by means of a different colour, printing, knurling, roughening, or the like, or the xe2x80x9ccompressible partsxe2x80x9d may be defined by weakening lines, or the like. When a user or patient is using the preferred embodiment of the device according to the invention for transferring a powdered or particulate substance into his nostril or nostrils he may grip the xe2x80x9ccompressible partsxe2x80x9d of the tubular body between his thumb and indexing finger and compress, pinch, or deflate such parts. When the user has inserted the nasal piece of the device into his nostril and placed the mouthpiece between his lips he may blow forcefully into the mouthpiece to build up a high pressure therein. Then he may release the compressible parts whereby the compressed parts are suddenly inflated and expanded so that the air may flow freely through the unobstructed inner cavity of the tubular body. The pressure being established within the oral cavity when the user is blowing while the compressible parts are deformed causes the uvula to efficiently close the connection between the nostrils and the throat.
It should be understood that the restriction means may comprise any other kind of means adapted to move from their first restricting position to their second less restricting or non-restricting position when a user is blowing into the first end of the tubular body so as to create a pressure difference between said first and second end of the tubular body exceeding a predetermined value.
The method and device according to the invention may also be used for introducing a gel-like substance into a nostril. This means that the powdered or particulate substance may be replaced by such gel-like active substance.
The invention further provides a device for dispersing a powdered or particulate substance in an airflow, said device comprising a tubular body defining a flow passage therein and a dose of powdered or particulate active substance arranged within the flow passage, the tubular body having a mouthpiece at one end to be inserted between the lips of a user so that the user may blow into or inhale through the mouthpiece end of the flow passage so as to disperse said dose of powdered or particulate substance into the air flowing through the flow passage, and the device according to the invention is characterised in that cross-sectional restriction means are arranged within the flow passage upstream of the dose of active substance moveable between a first closing or restricting position and a second position in which no or substantially less restriction is defined by the restriction means, the restriction means being adapted to move from their first restricting position to their second, less restricting position when a user is blowing into the mouthpiece end of the tubular body so as to create a pressure difference between said mouthpiece and nasal piece ends of the tubular body exceeding a predetermined value. Such device may be used not only for transferring powdered or particulate product to a nostril, but also as an inhaler. The tubular body and the restriction means may be of any type described herein.